NCT01329627终止2 期
Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer
Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of febrile neutropenia
研究概览
简要总结
The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Locally advanced breast cancer diagnosed by guided core biopsy
- •T > 2 cm (any N), or any T and node positive (needle biopsy is required)
- •Non-metastatic disease assessed by computed tomography and bone scintigraphy
- •Histological grade 2 and Ki67 > 15% or
- •Histological grade 3 or
- •Any triple negative (TN) or
- •Inflammatory breast cancer (IBC)
- •Normal left ventricular ejection fraction (LVEF)
- •HER2-negative disease
排除标准
- •Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
- •Clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders
- •LVEF value below institutional limits of normal
- •Predominant lobular carcinoma histology
- •Grade 1 tumors
- •Detected or suspicious distant metastasis
- •Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than 10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than ULN, alkaline phosphatase more than 1.5x ULN
- •HER2-positive breast cancer
研究组 & 干预措施
Paclitaxel/doxorubicin/cyclophosphamide
Experimental
干预措施: Paclitaxel/doxorubicin/cyclophosphamide (Drug)
结局指标
主要结局
Incidence of febrile neutropenia
时间窗: 18 weeks
Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%
次要结局
- Efficacy(From the beginning of treatment until surgery, progression and death)
研究者
研究点 (1)
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